Label: information for the user

Trepulmix 1mg/ml infusion solution

Trepulmix 2.5mg/ml infusion solution

Trepulmix 5mg/ml infusion solution

Trepulmix 10mg/ml infusion solution

treprostinil

Read this label carefully before starting to use this medication, as it contains important information for you.

What is Trepulmix

The active ingredient of Trepulmix is treprostinil.

Treprostinil belongs to a group of medications that act in a similar way to natural prostacyclins. Prostacyclins are substances similar to hormones that decrease blood pressure by relaxing blood vessels, causing them to dilate and allowing blood to flow more easily. Prostacyclins can also influence preventing blood coagulation.

What is Trepulmix used for

Trepulmix is used for the treatment of adult patients with chronic inoperable pulmonary arterial hypertension (PAH) or persistent or recurrent PAH after surgical treatment (classified as World Health Organization functional class III or IV), to improve exercise capacity and symptoms of the disease. Chronic pulmonary arterial hypertension is a condition in which blood pressure is too high in the blood vessels between the heart and lungs, causing shortness of breath, dizziness, fatigue, fainting, palpitations or abnormal heartbeats, dry cough, chest pain, and swollen legs or ankles.

How Trepulmix works

Trepulmix reduces blood pressure within the pulmonary artery by improving blood flow and reducing the amount of work the heart has to do. By improving blood flow, a greater supply of oxygen is delivered to the body and less tension is placed on the heart, allowing it to function more efficiently. Trepulmix improves symptoms associated with PAH and exercise capacity in patients with limitations on activity.

Do not use Trepulmix

• a heart attack (myocardial infarction) that occurred in the last six months;
• severe alteration of heart rate;
• severe ischemic heart disease or unstable angina;
• you have been diagnosed with a heart defect, such as a faulty heart valve that makes the heart function poorly;
• any heart disease that is not being treated or is not being closely monitored by a doctor.
• • if you have a specific high risk of bleeding, for example, active stomach ulcers, wounds, or other bleeding conditions;
  • if you have had a stroke in the last 3months or any other interruption of blood supply to the brain.

Warnings and precautions

Consult your doctor before starting to use Trepulmix if you:

During your treatment with Trepulmix, inform your doctor:

Children and adolescents

Trepulmix should not be used in children and adolescents.

Other medications and Trepulmix

Inform your doctor if you are taking/using, have taken/used recently, or may need to take/use any other medication. Inform your doctor if you are taking:

Pregnancy and breastfeeding

Trepulmix is not recommended if you are pregnant, planning to become pregnant, or think you may be pregnant, unless your doctor considers it essential. The safety of this medication during pregnancy has not been established.

It is strongly recommended to use contraceptive methods during treatment with treprostinil.

Trepulmix is not recommended during breastfeeding, unless your doctor considers it essential. It is recommended that you stop breastfeeding if you are prescribed Trepulmix, as it is not known if this medication passes into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medication.

Driving and operating machinery

Trepulmix may cause hypotension with dizziness or fainting. In this case, do not drive or operate machinery and consult your doctor.

Trepulmix contains sodium

Inform your doctor if you are on a low-sodium diet. He will take this into account.

Trepulmix 1mg/ml infusion solution

This medication contains36.8mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 1.8% of the maximum daily recommended sodium intake for an adult.

Trepulmix 2.5mg/ml infusion solution

This medication contains37.3mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 1.9% of the maximum daily recommended sodium intake for an adult.

Trepulmix 5mg/ml infusion solution

This medication contains39.1mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 2.0% of the maximum daily recommended sodium intake for an adult.

Trepulmix 10mg/ml infusion solution

This medication contains37.4mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 1.9% of the maximum daily recommended sodium intake for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Trepulmix is administered undiluted through subcutaneous continuous infusion (under the skin) through a small tube (cannula) located in your abdomen or thigh;

Trepulmix is driven through the tube by a portable pump.

Before leaving the hospital or clinic, your doctor will instruct you on how to prepare Trepulmix and the speed at which the pump should administer treprostinil. They should also provide you with information on how to use the pump correctly and what to do if it stops working. Additionally, they should inform you of whom to contact in case of an emergency.

Washing the infusion line while it is connected can cause an accidental overdose.

Adult patients

Trepulmix is available as a perfusion solution of 1 mg/ml, 2.5 mg/ml, 5 mg/ml, or 10 mg/ml. Your doctor will determine the infusion rate and the appropriate dose for your condition.

Geriatric patients

No special dose adjustment is required in these patients.

Patients with severe liver or kidney disease

Your doctor will determine the infusion rate and the appropriate dose for your condition.

Infusion rate

The infusion rate can be reduced or increased individuallyonly under medical control.

The goal of adjusting the infusion rate is to establish an effective maintenance rate that improves symptoms of PAH while minimizing adverse reactions.

If symptoms worsen or if you need to rest completely, or if you are confined to bed or chair, or if any physical activity causes discomfort and you experience symptoms at rest, do not increase the dose without consulting a doctor. It is possible that Trepulmix is no longer sufficient to treat your condition and that you require another treatment.

If you use more Trepulmix than you should

If you have an accidental overdose of Trepulmix, you may experience nausea, vomiting, diarrhea, hypotension (dizziness, drowsiness, or fainting), skin redness, and/or headaches.

If any of these effects worsen, you should contact your doctor or hospital immediately. Your doctor may reduce or interrupt the infusion until your symptoms have disappeared. The Trepulmix perfusion solution will be reintroduced at the dose recommended by your doctor.

If you interrupt treatment with Trepulmix

Always use Trepulmix following the instructions of your doctor or hospital specialist. Do not stop using Trepulmix unless your doctor has recommended it.

Abrupt withdrawal or sudden reductions in the dose of Trepulmix can cause pulmonary arterial hypertension to return with the possibility of rapid and severe deterioration of your condition.

If you have any other doubts about the use of this medication, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Very common (may affect more than 1 in 10 people)

• vasodilation
• pain around the infusion site
• reaction around the infusion site
• bleeding or hematomas around the infusion site
• headaches
• nausea
• diarrhea
• jaw pain

Common (may affect up to 1 in 10 people)

• dizziness
• fatigue or fainting due to arterial hypotension
• skin eruptions
• infection at the infusion site
• pus around the infusion site (abscess)
• muscle pain (myalgia)
• joint pain (arthralgia)
• swelling of feet, ankles, legs, or fluid retention
• flushes
• pain in arms and/or legs

Rare (may affect up to 1 in 100 people)

• swollen eyelids (periorbital edema)
• indigestion
• vomiting
• itching in the skin
• exanthema
• back pain
• loss of appetite
• fatigue

Other possible side effects observed in patients with pulmonary arterial hypertension (PAH):

• hemorrhagic episodes such as: nasal bleeding, coughing up blood, blood in urine, bleeding gums, blood in stool

Other possible side effects observed in clinical practice:

• decrease in blood cells responsible for blood clotting (platelets) in the blood (thrombocytopenia)
• bone pain
• skin eruptions with discoloration or raised areas
• infection of the tissue under the skin (cellulitis)

Reporting of side effects

If you experience any type of side effect, consult your doctor,even if it is a side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Maintain this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and vial after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

A vial of Trepulmix should be used or discarded within 30 days after its first opening.

During continuous subcutaneous infusion, a single reservoir (syringe) of undiluted Trepulmix should be used within 72 hours.

Do not use this medication if you observe damage to the vial, discoloration, or other signs of deterioration.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Trepulmix

• The active ingredient is treprostinil

Trepulmix 1mg/ml solution for infusion

Each ml of solution contains 1mg of treprostinil (as sodium salt).

Each vial of solution of 10ml contains 10mg of treprostinil (as sodium salt).

Trepulmix 2.5mg/ml solution for infusion

One ml of solution contains 2.5mg of treprostinil (as sodium salt)

Each vial of solution of 10ml contains 25mg of treprostinil (as sodium salt).

Trepulmix 5mg/ml solution for infusion

Each ml of solution contains 5mg of treprostinil (as sodium salt).

Each vial of solution of 10ml contains 50mg of treprostinil (as sodium salt).

Trepulmix 10mg/ml solution for infusion

Each ml of solution contains 10mg of treprostinil (as sodium salt).

Each vial of solution of 10ml contains 100mg of treprostinil (as sodium salt).

• The other components are:
• Sodium citrate, sodium chloride, sodium hydroxide, hydrochloric acid, metacresol and water for injection. See section2 "Trepulmix contains sodium".

Appearance of the product and contents of the pack

Trepulmix is a transparent, colourless to slightly yellowish solution, available in a transparent glass vial of 10ml sealed with a rubber stopper and a colour-coded cap:

Trepulmix 1mg/ml solution for infusion

Trepulmix 1mg/ml solution for infusion has a yellow rubber stopper.

Trepulmix 2.5mg/ml solution for infusion

Trepulmix 2.5mg/ml solution for infusion has a blue rubber stopper.

Trepulmix 5mg/ml solution for infusion

Trepulmix 5mg/ml solution for infusion has a green rubber stopper.

Trepulmix 10mg/ml solution for infusion

Trepulmix 10mg/ml solution for infusion has a red rubber stopper.

Each box contains onevial.

Only some pack sizes may be marketed.

Marketing authorisation holder

SciPharm Sàrl

7, Fausermillen

L-6689 Mertert

Luxembourg

Responsible person

AOP Orphan Pharmaceuticals GmbH

Leopold-Ungar-Platz

21190 Vienna

Austria

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:.

Detailed information on this medicinal product is available on the website of the European Medicines Agency: .https://www.ema.europa.eu.There are also links to other websites on rare diseases and orphan medicinal products.